(B)(1) The public health council, in accordance with
Chapter | 14 |
|
119. of the Revised Code, shall adopt, and may amend or
rescind, | 15 |
|
rules establishing reasonable fees to be charged for
services that | 16 |
|
the laboratory performs. The council
need not
prescribe fees to | 17 |
|
be charged in any case where the council
believes that the | 18 |
|
charging of fees would significantly and
adversely affect the | 19 |
public health.
Except
as provided in
division
(B)(2)
of
this | 20 |
section, allAll fees collected
for services
that
the laboratory | 21 |
|
performs shall be
deposited into
the state
treasury
to the credit | 22 |
|
of the "laboratory handling fee
fund,"
which is
hereby created for | 23 |
|
the purpose of defraying
expenses of
operating
the laboratory. | 24 |
(2) The council, in accordance with division (B)(1) of
this | 25 |
section, shall adopt a rule establishing a fee of not less
than | 26 |
fourteen dollars for tests of newborn children
conducted
under | 27 |
section 3701.501 of the Revised Code. Of each such fee
collected | 28 |
on or after the rule's effective date, not less than ten
dollars | 29 |
and
twenty-five cents shall be deposited into the state treasury | 30 |
to
the credit of the genetics services fund, which is hereby | 31 |
created, and not less than three dollars and seventy-five cents | 32 |
shall
be
deposited into the state treasury to the credit of the | 33 |
sickle
cell fund, which is hereby created. Not less than three | 34 |
dollars from each fee
credited to the genetics services fund shall | 35 |
be used to defray
costs of phenylketonuria programs. Not less | 36 |
than seven
dollars and twenty-five
cents of each fee credited to | 37 |
the genetics services fund shall be
used to defray the costs of | 38 |
the programs authorized by section
3701.502 of the Revised Code. | 39 |
Money credited to the sickle cell
fund shall be used to defray | 40 |
costs of programs authorized by
section 3701.131 of the Revised | 41 |
Code. | 42 |
Sec. 3701.501. (A)
The public health council shall adopt | 43 |
rules in accordance with Chapter 119. of the Revised Code for | 44 |
testing of(1) Except as provided in division (A)(2) of this | 45 |
|
section,
all newborn children
shall be screened for the presence | 46 |
of
phenylketonuria,
homocystinuria, galactosemia, and | 47 |
hypothyroidism.
The person
designated in the rules shall cause a | 48 |
child to be
tested in
accordance with the rules. The rules may | 49 |
require tests
for otherthe
genetic, endocrine,
orand metabolic | 50 |
disorders
if
the following
conditions are met: | 51 |
All tests required by this section or by rules adopted by
the | 57 |
public health council pursuant to this section shall be
performed | 58 |
by the laboratory authorized by section 3701.22 of the
Revised | 59 |
Code except that if the rules adopted by the public
health council | 60 |
under this section provide that retesting of
children with | 61 |
abnormal test results may be performed by
laboratories other than | 62 |
that laboratory, retests may be performed
by any laboratory | 63 |
approved by the director of health for that
purpose. | 64 |
Rules adopted by the public health council under this
section | 65 |
shall prescribe a method for giving notice of the
proposed tests | 66 |
and the results of the tests to the parents of the
child. The | 67 |
rules shall also prescribe a method for giving notice
of the | 68 |
proposed tests and the results of the tests to either the
person | 69 |
who caused the child to be tested, employees designated by
the | 70 |
rules of the hospital of birth, or the health commissioner
for the | 71 |
health district where the birth occurred, whichever is
appropriate | 72 |
as determined by the rules. | 73 |
The rules also shall
prescribe laboratory methods and other | 74 |
procedures for the
detection of such genetic, endocrine, and | 75 |
metabolic disorders in
newborn children, including procedures for | 76 |
retesting and referral
of children with abnormal test results. | 77 |
With regard to tests for the
presence of phenylketonuria, the | 78 |
laboratory methods and other procedures
prescribed in the rules | 79 |
shall include any test that the council determines is
effective | 80 |
for use in
detecting the disorder in children who are less than | 81 |
forty-eight hours old. | 82 |
| (B) There is hereby created the newborn screening advisory | 87 |
|
council to advise the director of health regarding the screening | 88 |
|
of newborn children for genetic, endocrine, and metabolic | 89 |
|
disorders. The council shall engage in an ongoing review of the | 90 |
|
newborn screening requirements established under this section and | 91 |
|
shall provide recommendations and reports to the director as the | 92 |
|
director requests and as the council considers necessary. The | 93 |
|
director may assign other duties to the council, as the director | 94 |
|
considers appropriate. | 95 |
|
The director shall appoint the members of the council. In | 96 |
|
making appointments, the director shall select individuals and | 97 |
|
representatives of entities with interest and expertise in newborn | 98 |
|
screening, including such individuals and entities as health care | 99 |
|
professionals, hospitals, children's hospitals, regional genetic | 100 |
|
centers, regional sickle cell centers, newborn screening | 101 |
|
coordinators, and members of the public. | 102 |
|
(3) Based on the considerations specified in division | 129 |
|
(C)(2) of this section, the council shall make recommendations to | 130 |
|
the director of health for the adoption of rules under division | 131 |
|
(C)(1) of this section. The director shall promptly and | 132 |
|
thoroughly review each recommendation the council submits. If the | 133 |
|
director agrees with a recommendation made by the council, the | 134 |
|
director shall adopt rules that correspond with the | 135 |
|
recommendation. | 136 |
|
(2) If the director determines that the laboratory | 164 |
|
authorized under section 3701.22 of the Revised Code is unable to | 165 |
|
perform screenings for all of the disorders specified in the rules | 166 |
|
adopted under division (C) of this section, the director shall | 167 |
|
select another laboratory to perform the screenings. The director | 168 |
|
shall select the laboratory by issuing a request for proposals. | 169 |
| The director may accept proposals submitted by laboratories | 170 |
| located outside this state. At the
conclusion of the selection | 171 |
| process, the director shall enter into
a written contract with the | 172 |
| selected laboratory. If the director
determines that the | 173 |
| laboratory is not complying with the terms of
the contract, the | 174 |
| director shall immediately terminate the
contract and another | 175 |
| laboratory shall be selected and contracted
with in the same | 176 |
| manner. | 177 |
|
(3) Any rescreening caused to be performed pursuant to this | 178 |
|
section may be performed by the laboratory authorized
by section | 179 |
|
3701.22 of the Revised Code or one or more other
laboratories | 180 |
|
designated by the director. Any laboratory the
director considers | 181 |
|
qualified to perform rescreenings may be
designated, including a | 182 |
| laboratory located outside this state.
If more than one laboratory | 183 |
| is designated, the person responsible for causing a
rescreening to | 184 |
| be performed
is also responsible for selecting the
laboratory to | 185 |
| be used. | 186 |
| (a) Not less than ten dollars and twenty-five cents shall be | 193 |
|
deposited in the state treasury to the credit of the genetics | 194 |
|
services fund, which is hereby created. Not less than seven | 195 |
|
dollars and twenty-five cents of each fee credited to the genetics | 196 |
|
services fund shall be used to defray the costs of the programs | 197 |
|
authorized by section 3701.502 of the Revised Code. Not less than | 198 |
|
three
dollars from each fee credited to the genetics services fund | 199 |
|
shall
be used to defray costs of phenylketonuria programs. | 200 |